Nonclinical Drug Safety Requirements to Open an IND/FIM Trial
Date: February 12, 2008
Time: 8:30 a.m. - 9:30 a.m.
Location: Pharmatek Laboratories, Inc.
Speaker: Shayne Cox Gad, Ph.D., D.A.B.T., ATS, Principal, Gad Consulting Services
Presentation Summary
Dr. Gad’s presentation will provide knowledge on the strategic, scientific and regulatory basis for the non-clinical development of drugs. He will discuss how toxicology studies are integrated into the multidisciplinary development plans of new drugs, and how they affect development decisions. Requirements for testing the safety of a potential new drug, including the timing of drug safety testing, regulatory interactions, and project management and the creation of efficient development and regulatory strategies will be presented. There will be ample opportunities for attendees to introduce topics for discussion and to ask questions of Dr. Gad.
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About the Speaker
Shayne Cox Gad, Ph.D., D.A.B.T., ATS, is principal of Gad Consulting Services. His more than 30 years of experience includes safety assessment and product development in the pharmaceutical, biotechnology, medical device and chemical industries. Dr. Gad has directed the design, conduct, writing and successful filing of 75 complete INDs plus numerous BLAs, PLAs, 510(k)s, IDEs, NDAs, PMAs and CTDs. He has published 31 books and more than 300 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology and safety assessment.
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